NaturaLyte Heart Attack Lawsuit

The dialysis product NaturaLyte is used to neutralize acid that normally builds up in blood during dialysis. Unfortunately, NaturaLyte was recalled in June 2012 after it was linked to lethal cardiovascular risks, including heart attack and death. Fresenius, the manufacturer of NaturaLyte, is now facing lawsuits from injured people who allege that the company failed to warn about the side effects of NaturaLyte.

What You Can Do & How a NaturaLyte Heart Attack Lawsuit Can Help

The Schmidt Firm, PLLC is currently accepting NaturaLyte induced injury cases in all 50 states. If you or somebody you know has been injured by NaturaLyte, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Product Liability & Defective Drug Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.

Attorney Michael Schmidt Elected to the Granuflo and Naturalyte Plaintiffs’ Steering Committee for Injury Lawsuits Nationwide

Michael E. Schmidt, Managing Partner of Schmidt & Clark, LLP and The Schmidt Firm, PLLC, was recently elected to the Plaintiffs’ Steering Committee in the Judicial Council Coordination Proceeding No. 4749 in Los Angeles Superior Court. The coordination proceeding applies to Granuflo and Naturalyte injury claims nationwide.  This appointment establishes Mr. Schmidt in a leadership position in the litigation along with rest of the JCCP leadership panel.
 
A nationwide recall was issued for NaturaLyte and GranuFlo on March 29, 2012.  Use of Fresenius Medical Care’s popular dialysis treatment products GranuFlo and NaturaLyte has been linked to a six-fold increased risk of cardiopulmonary arrest and sudden cardiac death.

What’s the problem?

Naturalyte Liquid Acid Concentrate is a substance that balances the acidity of blood during hemodialysis. It consists of sodium diacetate and acetic acid. It was created by Fresenius Medical Care, the world’s leading provider of dialysis products.

Fresenius operates the majority of dialysis clinics in the U.S. — more than 1,800, which serve more than 400,000 people who are suffering from end-stage kidney disease. Because the waiting list for a new kidney transplant is about 5 years, many people undergo dialysis several times a week. During dialysis, the patient’s blood is removed from their body, mechanically cleaned of toxins and excess fluid, and returned to the body.

During dialysis, the acidity of blood increases. Bicarbonate is used most extensively to reduce the acidity. Doctors typically mix an acid concentrate with a bicarbonate concentrate. Unfortunately, NaturaLyte contains sodium diacetate in concentrations higher than most other acid concentrate products. Sodium diacetate is rapidly converted to bicarbonate by the patient’s body — effectively leading to a higher amount of bicarbonate than what was initially prescribed.

If a physicians does not compensate for the increased bicarbonate in NaturaLyte, a patient may suffer a bicarbonate overdose and a life-threatening condition called metabolic alkalosis.

Failure to Warn about NaturaLyte Risks

There is evidence that Fresenius failed to warn about the serious risks associated with NaturaLyte. On June 15, 2012, New York Times reported that the U.S. Food and Drug Administration (FDA) was investigating Fresenius for potentially failing to warn about known risks associated with NaturaLyte and GranuFlo.

According to the Times, on November 4, 2011, Fresenius staff sent an internal memo to doctors at their clinics. The memo reported an unusual increase in patient deaths at Fresenius clinics — 941 deaths in 2010 alone. After investigating these deaths, Fresenius concluded that patients with high bicarbonate levels before dialysis treatment had a 6-fold increased risk of cardiac arrest than other patients. Fresenius did not inform the FDA, doctors at other clinics, or the public about this risk.

In March 2012, an anonymous source leaked the internal memo to the FDA. Soon after, Fresenius sent a notice to all customers (including doctors at other clinics) to warn about the lethal risks of NaturaLyte and GranuFlo.

FDA Recalls NaturaLyte

Fresenius voluntarily issued a Class 1 recall of NaturaLyte on June 27, 2012. According to the FDA:

“Inappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis. This may contribute to metabolic alkalosis, which is a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which, if not appropriately treated, may culminate in cardiopulmonary arrest. This product may cause serious adverse health consequences, including death.”

NaturaLyte and Heart Attacks

Severe cardiovascular events (including heart attack) can occur when doctors do not administer the correct dose of NaturaLyte. A bicarbonate overdose can disrupt the normal pH of the patient’s blood and lead to a life-threatening condition called metabolic alkalosis.

Severe side effects of NaturaLyte include:

• Cardiac arrest
• Heart attack
• Cardiopulmonary arrest
• Stroke
• Irregular heart rhythm (arrhythmia)
• Low blood pressure
• Permanent disability
• Death

Do I have a NaturaLyte Heart Attack Lawsuit?

The Schmidt Firm, PLLC is currently accepting NaturaLyte induced injury cases in all 50 states. If you or somebody you know has been injured by NaturaLyte, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Product Liability & Defective Drug Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.

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